New Organs on Command: The Regulatory Prospects of 3D Bioprinting Technology in the European Union
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Hertie School
Germany
Abstract
This article examines the evolving legal landscape of bioprinting in the European Union, focusing on the regulatory challenges posed by the hybrid nature of bioprinted products. These constructs – simultaneously biological and synthetic – defy conventional legal classifications and are conceptualised here as biosthetics. The analysis explores how existing EU regulatory instruments – including the ATMP Regulation, MDR, GDPR and SoHO Regulation – apply to bioprinting technologies across research and development as well as clinical implementation. The article argues that current frameworks, while comprehensive, remain fragmented and insufficiently adaptive to address the ontological and operational complexities of biosthetics entities. Three regulatory scenarios are presented: continued reliance on mode-of-action classification, incremental amendments to existing laws and the development of a novel regulatory model tailored to bioprinting. Ultimately, the article advocates for a paradigm shift towards anticipatory, participatory and ethically grounded governance that can respond to the challenges and promises of biomedical technologies in the biosthetics age.
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Author Biography
Mirko Đuković was born in Podgorica, Montenegro. He is a postdoctoral researcher and lecturer at the Hertie School’s Centre for Fundamental Rights. He teaches Human Rights & Emerging Technologies (MA level). He previously held a CIVICA fellowship at the EUI Department of Law. Mirko holds law degrees from the University of Montenegro, the University of Belgrade (LL.M.), and Kyushu University (LL.M.) and PhD from Central European University with a dissertation on biomedical technology regulation.
He has taught EU law, human rights, and international law in Montenegro, Hungary, Austria, and China. His research includes visiting fellowships at the Max Planck Institute, Oxford University, NOVA University, and Bologna University. His work centers on human rights, health law, new technologies regulation, ethics, and EU law
